How you can help us grow End­points News through the pan­dem­ic

We’re lucky at End­points News.

Read­er en­gage­ment is the high­est we’ve ever seen as we ap­proach 80,000 dai­ly email sub­scribers — with over 20% of them un­der a paid plan. Busi­ness op­er­a­tions are strong, with our team of 17 de­ployed at home of­fices across the US, Eu­rope, and Asia be­fore it be­came manda­to­ry. And we can sell ad­ver­tis­ing to clients who need to reach a hy­per-fo­cused au­di­ence. It’s a way of reach­ing out, with­out touch­ing, that has be­come in­creas­ing­ly trendy. The vir­tu­al na­ture of our busi­ness gives us a few crit­i­cal ad­van­tages in re­spond­ing to the cri­sis.

There are chal­lenges, of course.

Live events ac­count for a third of our rev­enues — or used to, at least. Con­nect­ing the bio­phar­ma world is a vi­tal part of our mis­sion, and there’s no re­al sub­sti­tute for mak­ing new per­son­al con­nec­tions at con­fer­ences.

So un­til we’re able to meet in close quar­ters again — stretch­ing well in­to 2021 — all End­points events will be vir­tu­al. We’re start­ing with an ag­gres­sive slate of vir­tu­al Zoom pan­els fea­tur­ing the in­dus­try’s top lead­ers. We’ll have more on that soon. And the team is look­ing at new and in­no­v­a­tive ways at de­liv­er­ing these events, be­yond the stan­dard video pan­els. There’s a huge op­por­tu­ni­ty to reimag­ine on­line con­fer­ences and the val­ue they bring to both at­ten­dees and spon­sors.

To be sure, the bio­phar­ma in­dus­try it­self is demon­strat­ing some re­al re­silience in the cri­sis. That’s im­por­tant. Bio­phar­ma will be back, al­tered — cer­tain­ly — but more fo­cused on big things than ever be­fore.

We’re look­ing for­ward to writ­ing about that.

While we’ve been fo­cused on cov­er­ing the out­break and its im­pact on the in­dus­try — our spe­cial niche — we’ve put few­er sto­ries be­hind the pay­wall. That will change soon, and we need your sup­port now more than ever.

Up­grad­ing to a pre­mi­um plan

The best way to sup­port End­points News is for your com­pa­ny to pur­chase an En­ter­prise sub­scrip­tion. It’s a trans­par­ent­ly priced, flat-rate plan that cov­ers all em­ploy­ees at your or­ga­ni­za­tion, start­ing at $1,000/year. That grants ac­cess to our en­tire pay­wall li­brary and con­fers a li­cense for your com­pa­ny to reprint and share our con­tent in­ter­nal­ly as you please.

In­di­vid­u­als can sign up for an In­sid­er plan, which is now $225/year. In ad­di­tion to the pay­wall li­brary, In­sid­ers can dis­able all ad­ver­tis­ing. If you want to read just the con­tent and noth­ing else, this is the plan for you.

We’ll con­tin­ue to of­fer the bulk of our sto­ries for free ac­cess. But any com­pa­ny or in­di­vid­ual look­ing for the com­plete pic­ture should get a paid sub­scrip­tion. The prices are af­ford­able, trans­par­ent, and pro­vide a ton of val­ue.

Most im­por­tant­ly, with both plans, you’re di­rect­ly sup­port­ing the fu­ture de­vel­op­ment of End­points News.

It’s our paid sub­scribers — who’ve been with us years — that put us in the dri­ver’s seat, in charge of our des­tiny, nav­i­gat­ing the big changes ahead for the me­dia busi­ness. With your sup­port, we’ll keep build­ing the staff through the tough times ahead.

For those of you who have a paid sub, thank you. For those of you get­ting one to­day, be sure that we have nev­er been more ap­pre­cia­tive of your sup­port for the in­de­pen­dent mis­sion we have carved out for our­selves as we boot­strapped this start­up.

You can sign up here. If you have spe­cial re­quests, you can open up a chat with our sup­port team at this page.

And if you need to reach our bio­phar­ma au­di­ence with a pro­mo­tion­al cam­paign, please drop a line to our rev­enue chief, Mike Peck (mike@end­pointsnews.com). We are open for (vir­tu­al) busi­ness 24/7.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,400+ biopharma pros reading Endpoints daily — and it's free.